Encore Medical Recalls EMPOWR 3D Knee Tibial Inserts Over Packaging Errors
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Encore Medical, LP has issued a voluntary recall for EMPOWR 3D Knee Tibial Inserts due to packaging discrepancies that may lead to surgical delays or revision surgeries.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 18, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Encore Medical, LP has initiated a voluntary recall of the EMPOWR 3D Knee Tibial Insert and certain acetabular systems. The recall was prompted by the discovery of a packaging discrepancy where a package labeled as a 942-01-40G acetabular system actually contained a 942-01-36H system. The firm noted that other knee insert devices may also be affected by similar labeling errors, which could lead to incorrect components being present during surgical procedures.
Which Products Are Affected
The recall specifically identifies the following medical device:
- Product Name: EMPOWR 3D Knee Tibial Insert 5R 14MM, VE
- Reference Number (REF): 342-14-705
- Recall Number: Z-1233-2026
- Lot Number: 139T1075A
- UDI-DI: 00888912167529
- Expiration Date: 03-12-2026
- Quantity: 19 units
The affected units were distributed across several states and territories, including: Alabama, California, Iowa, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, Texas, and Puerto Rico.
What You Should Do
Healthcare facilities, surgeons, and medical supply managers should immediately inspect their inventory for the affected lot number (139T1075A). Any identified units should be quarantined and removed from surgical availability to prevent use. Facilities should contact Encore Medical, LP at their Austin, Texas office for further instructions regarding the return or exchange of the mislabeled devices.
Why This Matters
Packaging discrepancies in surgical components pose a significant risk to patient safety. Such errors can result in unexpected surgical delays while staff attempt to source the correct device or, in more serious cases, may necessitate revision surgery if an incorrect component is implanted before the error is identified.
Source
This information is based on an official recall notice from the FDA.
Original source: FDA Official Notice ↗
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